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NCT05677100 · ClinicalTrials.gov record · last posted 2026-08-25

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure

Name: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure — clinical trial record (NCT05677100)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: DRAIN-HF

StatusRecruiting

PhaseNot applicable

SponsorProcyrion

Started2023-08-23

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy. Eligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management.

Protocol amendment history 2 changes detected by DataLookout

2026-08-05

Primary completion pushed: 2027-01 → 2028-01

2026-08-05

Completion pushed: 2027-08 → 2028-08

Trial Details

NCT Number	NCT05677100
Lead Sponsor	Procyrion
Conditions	Heart Failure, Cardiorenal Syndrome, Cardio-Renal Syndrome, ADHF, Heart Failure, Systolic, Heart Failure, Diastolic, Heart Failure; With Decompensation, Heart Failure, Congestive
Enrollment	320 participants
Start Date	2023-08-23
Primary Completion	2028-01 (estimated)
Study Completion	2028-08 (estimated)
Updated on ClinicalTrials.gov	2026-08-25